External Wounds Measured for Length by Width Using a RulerNCT01869439

Measuring Wounds Found on the Outside of the Body Surface

A study testing "gold standard" LxW manual ruler measurement technique, WMMS ImageReview software's LxW measurement technique and WMMS ImageReview software's Visual External Wound Trace in people with External Wounds Measured for Length by Width Using a Ruler, run by Wound Vision at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test wounds found on the outside of the body surface with an investigational medical imaging device that collects visual pictures and thermal digital pictures of the wound site. The investigational device has not been approved by the Food and Drug Administration (FDA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: External Wounds Measured for Length by Width Using a Ruler
What is being tested?: "gold standard" LxW manual ruler measurement technique, WMMS ImageReview software's LxW measurement technique and WMMS ImageReview software's Visual External Wound Trace
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: May 2013to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 or greater, of either gender and of any ethnic background
Able to tolerate position changes and turns for up to 10 minutes comfortably
Have an existing external wound that is currently measured for length and width using a ruler
The protocol will allow imaging up to 3 external wounds per subject
The 3 external wounds must be in separate body locations (ex: one on the right heel, one on the left heel, and the other on the sacrum).
Have qualifying external wound sites:
External wounds whose external wound site fits entirely within the field of view and do not wrap around a body edge.
No device or treatment will obscure the external wound site

Who cannot join

Neonatal and pediatric patients
Pregnant women
Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)
Cannot be positioned so images can be taken at approximately 90 degrees perpendicular and 18 inches away from the external wound site
On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
Have external wound dressing or medical device which cannot or should not be removed as determined by site investigator

Show all 12Show fewer

Have an external wound with excessive or heavy exudate that cannot be controlled during the imaging session. Excessive drainage can obscure external wound features
Have complex external wound site(s):
The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view
From visual assessment the existing external wound cannot be clearly distinguished from other conditions at the external wound site (e.g. break down or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of wounds makes determining the edge of the external wound impossible)
Have not provided signed informed consent
Non-English speaking

Trial locations and contacts

2 sites in 1 country.

United States2 sites

St. Vincent Seton Specialty Hospital
Indianapolis, Indiana, 46260
St. Vincent Wound Healing Center
Indianapolis, Indiana, 46260

Other trials in United States

About this study

Official title: Utilizing Visual and Thermal Images for the Measuring and Monitoring of External Wounds

The medical imaging device is non-contacting and is non-radiating (delivers no energy to the body). It passively collects pictures (typical digital color photographs)and thermal pictures (black and white digital photographs of heat at the body surface.)

Read the detailed description

This prospective study utilizes the WoundVision Wound Measuring and Monitoring System (WMMS) to study external wounds, which can currently be measured for length by width using a ruler. WMMS operates by taking simultaneous visual and thermal images of the external wound site and the associated body surface. These images are evaluated by utilizing the WMMS ImageReview measuring and monitoring software. WMMS ImageReview software allows for LxW (length by width) and surface area (cm squared),as well as perimeter (cm) external wound measurements of the visual image. WMMS ImageReview software also allows for the display of thermal intensity variation data for the associated body surface of the corresponding thermal image.

This study is primarily designed to utilize the Coefficients of Individual Agreement (CIA)as a means of establishing the equivalence of area measurements utilizing the WMMS ImageReview software LxW technique and the current "gold standard" LxW manual ruler technique.

A secondary objective measures the thermal intensity variation data of the external wound bed by overlaying the corresponding "Visual External Wound Trace"from the visual image onto the thermal wound bed.

Conditions: External Wounds Measured for Length by Width Using a Ruler
Being tested: "gold standard" LxW manual ruler measurement technique, WMMS ImageReview software's LxW measurement technique, WMMS ImageReview software's Visual External Wound Trace, WMMS ImageReview software's External Wound Trace Overlay
Keywords: Pressure Ulcers, Bed Sores, Measuring, Visual Images, Thermal Images, External Wounds, Area, Length, Width, Gradient
Medical subject headings: Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"gold standard" LxW manual ruler measurement techniqueDevice
Currently, the "gold standard" LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).
WMMS ImageReview software's LxW measurement techniqueDevice
This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).
WMMS ImageReview software's Visual External Wound TraceDevice
This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image.
WMMS ImageReview software's External Wound Trace OverlayDevice
This measurement technique is a feature of the WMMS, utilizing the visual external wound trace and overlaying it onto the thermal wound site. From the thermal overlay, variation data such as the differences in the thermal intensities (gradient), mean, and the mode of the thermal wound bed can be measured.

Study groups in NCT01869439
Study group	Role	What they receive
External wounds measured for length by width using a ruler	Experimental	This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds. Receives: Device: "gold standard" LxW manual ruler measurement technique; Device: WMMS ImageReview software's LxW measurement technique; Device: WMMS ImageReview software's Visual External Wound Trace; Device: WMMS ImageReview software's External Wound Trace Overlay

What is being measured

The primary outcome is the main question the study is designed to answer.

Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.
Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Dec 2013

First posted5 Jun 2013 (estimated)
Study startMay 2013
Primary completionJun 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for External Wounds Measured for Length by Width Using a RulerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01869439
Sponsor's protocol ID: WV12CL-0003 Revision 09
Status last verified: Oct 2017
First submitted: 22 May 2013
Last updated: 6 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilizing Visual and Thermal Images for the Measuring and Monitoring of External Wounds
ClinicalTrials.gov ID: NCT01869439
Acronym / sponsor ID: WV12CL-0003 Revision 09
Conditions: External Wounds Measured for Length by Width Using a Ruler
Keywords: Pressure Ulcers, Bed Sores, Measuring, Visual Images, Thermal Images, External Wounds, Area, Length
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Wound VisionIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Jun 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 5 Jun 2013 (estimated)
Results: Posted 6 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
External wounds measured for length by width using a ruler	Experimental	Device: "gold standard" LxW manual ruler measurement technique, Device: WMMS ImageReview software's LxW measurement technique, Device: WMMS ImageReview software's Visual External Wound Trace, Device: WMMS ImageReview software's External Wound Trace OverlayThis is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18 or greater, of either gender and of any ethnic background
Able to tolerate position changes and turns for up to 10 minutes comfortably
Have an existing external wound that is currently measured for length and width using a ruler
Have qualifying external wound sites:

Key exclusion criteria (12 listed)

Neonatal and pediatric patients
Pregnant women
Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)
Cannot be positioned so images can be taken at approximately 90 degrees perpendicular and 18 inches away from the external wound site
On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
"gold standard" LxW manual ruler measurement techniqueCurrently, the "gold standard" LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).	Device	External wounds measured for length by width using a ruler
WMMS ImageReview software's LxW measurement techniqueThis software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).	Device	External wounds measured for length by width using a ruler
WMMS ImageReview software's Visual External Wound TraceThis is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image.	Device	External wounds measured for length by width using a ruler
WMMS ImageReview software's External Wound Trace OverlayThis measurement technique is a feature of the WMMS, utilizing the visual external wound trace and overlaying it onto the thermal wound site. From the thermal overlay, variation data such as the differences in the thermal intensities (gradient), mean, and the mode of the thermal wound bed can be measured.	Device	External wounds measured for length by width using a ruler

Primary outcome

Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Time frame: 90 Days
Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.

Results and safety

Results posted to the registry on 6 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wounds Measures of LxW Ruler & Software LxW, Area & Perimeter	40	40

Primary outcome: Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter

Time frame: 90 Days. Geometric mean (Geometric Coefficient of Variation). Unit: percentage of CV

Measure	Wounds Measured for Length by Width Using a Ruler and Software n = 40
Between Reader Software LxW Area	20.07 (16.71)
Between Reader Software Trace Area	16.28 (16.10)
Between Reader Software Perimeter	16.28 (5.82)
Within Reader Software Trace Area	20.07 (8.68)
Within Reader Area by Software Measurement	16.28 (6.46)
Within Reader Software Perimeter	16.28 (3.32)

Population analysed: 40 wounds captured in an inpatient and outpatient population.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
External Wounds Measured for Length by Width Using a Ruler	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

V. Chowdry Pinnamaneni, M.D. principal investigator

St.Vincent Wound Healing Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter (time frame: 90 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01869439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.